tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2024 Sep 26;11(10)
fae559.
doi: 10.1093/ofid/ofae559. eCollection 2024 Oct. Relative Effectiveness and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Versus Egg-Based Inactivated Influenza Vaccine Among Adults Aged 18-64 Years: Results and Experience From a Randomized, Double-Blind Trial
Lauren Grant[SUP] 1 [/SUP], Jennifer A Whitaker[SUP] 2 [/SUP], Sarang K Yoon[SUP] 3 [/SUP], Karen Lutrick[SUP] 4 [/SUP], Shivam Bhargava[SUP] 5 [/SUP], C Perry Brown[SUP] 6 [/SUP], Emily Zaragoza[SUP] 7 [/SUP], Rebecca V Fink[SUP] 8 [/SUP], Jennifer Meece[SUP] 9 [/SUP], Kristina Wielgosz[SUP] 1 [/SUP], Hana El Sahly[SUP] 2 [/SUP], Kurt T Hegmann[SUP] 3 [/SUP], Ashley A Lowe[SUP] 10 [/SUP], Alia Southworth[SUP] 5 [/SUP], Tanya Tatum[SUP] 6 [/SUP], Sarah W Ball[SUP] 8 [/SUP], Min Z Levine[SUP] 1 [/SUP], Matthew S Thiese[SUP] 3 [/SUP], Steph Battan-Wraith[SUP] 8 [/SUP], John Barnes[SUP] 1 [/SUP], Andrew L Phillips[SUP] 3 [/SUP], Alicia M Fry[SUP] 1 [/SUP], Fatimah S Dawood[SUP] 1 [/SUP]; Randomized Assessment of Influenza Vaccine Efficacy Network (RAIVEN)
Collaborators, Affiliations
Background: Immunogenicity studies suggest that recombinant influenza vaccine (RIV) may provide better protection against influenza than standard-dose inactivated influenza vaccines (SD IIV). This randomized trial evaluated the relative vaccine effectiveness (VE) and immunogenicity of RIV versus SD IIV in frontline workers and students aged 18-64 years.
Methods: Participants were randomized to receive RIV or SD IIV and followed for reverse-transcription polymerase chain reaction (RT-PCR)-confirmed influenza during the 2022-2023 influenza season. Sera were collected from a subset of participants before and at 1 and 6 months postvaccination and tested by hemagglutination inhibition for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria and against cell-grown vaccine reference viruses for A/H1N1 and A/H3N2.
Results: Overall, 3988 participants were enrolled and vaccinated (25% of the trial sample size goal); RT-PCR-confirmed influenza occurred in 20 of 1963 RIV recipients and 28 of 1964 SD IIV recipients. Relative VE was 29% (95% confidence interval [CI], -26% to 60%). In the immunogenicity substudy (n = 118), the geometric mean titer ratio (GMTR) comparing RIV to SD IIV at 1 month was 2.3 (95% CI, 1.4-3.7) for cell-grown A/H1N1, 2.1 (95% CI, 1.3-3.4) for cell-grown A/H3N2, 1.1 (95% CI, .7-1.6) for B/Victoria, and 1.4 (95% CI, .9-2.0) for B/Yamagata. At 6 months, GMTRs were >1 against A/H1N1, A/H3N2, and B/Yamagata.
Conclusions: Relative VE of RIV compared to SD IIV did not reach statistical significance, but RIV elicited more robust humoral immune responses to 2 of 4 vaccine viruses at 1 month and 3 of 4 viruses at 6 months after vaccination, suggesting possible improved and sustained immune protection from RIV. Clinical Trials Registration. NCT05514002.
Keywords: clinical trial; immunogenicity; influenza; influenza vaccines; relative effectiveness.
. 2024 Sep 26;11(10)
fae559.doi: 10.1093/ofid/ofae559. eCollection 2024 Oct. Relative Effectiveness and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Versus Egg-Based Inactivated Influenza Vaccine Among Adults Aged 18-64 Years: Results and Experience From a Randomized, Double-Blind Trial
Lauren Grant[SUP] 1 [/SUP], Jennifer A Whitaker[SUP] 2 [/SUP], Sarang K Yoon[SUP] 3 [/SUP], Karen Lutrick[SUP] 4 [/SUP], Shivam Bhargava[SUP] 5 [/SUP], C Perry Brown[SUP] 6 [/SUP], Emily Zaragoza[SUP] 7 [/SUP], Rebecca V Fink[SUP] 8 [/SUP], Jennifer Meece[SUP] 9 [/SUP], Kristina Wielgosz[SUP] 1 [/SUP], Hana El Sahly[SUP] 2 [/SUP], Kurt T Hegmann[SUP] 3 [/SUP], Ashley A Lowe[SUP] 10 [/SUP], Alia Southworth[SUP] 5 [/SUP], Tanya Tatum[SUP] 6 [/SUP], Sarah W Ball[SUP] 8 [/SUP], Min Z Levine[SUP] 1 [/SUP], Matthew S Thiese[SUP] 3 [/SUP], Steph Battan-Wraith[SUP] 8 [/SUP], John Barnes[SUP] 1 [/SUP], Andrew L Phillips[SUP] 3 [/SUP], Alicia M Fry[SUP] 1 [/SUP], Fatimah S Dawood[SUP] 1 [/SUP]; Randomized Assessment of Influenza Vaccine Efficacy Network (RAIVEN)
Collaborators, Affiliations
- PMID: 39416990
- PMCID: PMC11482004
- DOI: 10.1093/ofid/ofae559
Background: Immunogenicity studies suggest that recombinant influenza vaccine (RIV) may provide better protection against influenza than standard-dose inactivated influenza vaccines (SD IIV). This randomized trial evaluated the relative vaccine effectiveness (VE) and immunogenicity of RIV versus SD IIV in frontline workers and students aged 18-64 years.
Methods: Participants were randomized to receive RIV or SD IIV and followed for reverse-transcription polymerase chain reaction (RT-PCR)-confirmed influenza during the 2022-2023 influenza season. Sera were collected from a subset of participants before and at 1 and 6 months postvaccination and tested by hemagglutination inhibition for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria and against cell-grown vaccine reference viruses for A/H1N1 and A/H3N2.
Results: Overall, 3988 participants were enrolled and vaccinated (25% of the trial sample size goal); RT-PCR-confirmed influenza occurred in 20 of 1963 RIV recipients and 28 of 1964 SD IIV recipients. Relative VE was 29% (95% confidence interval [CI], -26% to 60%). In the immunogenicity substudy (n = 118), the geometric mean titer ratio (GMTR) comparing RIV to SD IIV at 1 month was 2.3 (95% CI, 1.4-3.7) for cell-grown A/H1N1, 2.1 (95% CI, 1.3-3.4) for cell-grown A/H3N2, 1.1 (95% CI, .7-1.6) for B/Victoria, and 1.4 (95% CI, .9-2.0) for B/Yamagata. At 6 months, GMTRs were >1 against A/H1N1, A/H3N2, and B/Yamagata.
Conclusions: Relative VE of RIV compared to SD IIV did not reach statistical significance, but RIV elicited more robust humoral immune responses to 2 of 4 vaccine viruses at 1 month and 3 of 4 viruses at 6 months after vaccination, suggesting possible improved and sustained immune protection from RIV. Clinical Trials Registration. NCT05514002.
Keywords: clinical trial; immunogenicity; influenza; influenza vaccines; relative effectiveness.